Vascular and InterventionalRadiology, Hospital Universitario Ramón y Cajal, M-607, km. 9, 100, 28034, Madrid, Spain; GITMI (Minimally Invasive Techniques Research Group), Zaragoza University, C/Miguel Servet 177, 50013, Zaragoza, Spain.
Head of Vascular and Interventional Radiology, Galdakao-Usansolo Hospital, Barrio Labeaga s/n, 48960, Galdakao, Vizcaya, Spain; Osakidetza Basque Health Service, Biocruces Bizkaia Health Research Institute, Cruces Plaza, 48903, Barakaldo, Vizcaya, Spain.
Eur J Radiol. 2020 May;126:108966. doi: 10.1016/j.ejrad.2020.108966. Epub 2020 Mar 19.
To assess the safety and tolerability of transarterial drug-eluting bead chemoembolisation (DEB-TACE) using tightly calibrated 100-μm microspheres in hepatocellular carcinoma (HCC).
This multicentre prospective study included 131 patients with a 2-year follow-up. All patients had Child-Pugh scores ≤ B7, a good performance status, and Barcelona Clinic Liver Cancer stage A or B. Beads were loaded with 50 mg of doxorubicin per millilitre. Overall, 223 nodules were treated (mean size: 27.6 mm, average number of nodules per patient: 1.7). Toxicity was assessed using Common Terminology Criteria for Adverse Events 4.03 and response according to the modified Response Evaluation Criteria in Solid Tumours. The primary endpoint was safety. Secondary endpoints included technical success, post-embolisation syndrome (PES), local tumour response, and 2-year survival.
A total of 214 DEB-TACE procedures were performed (mean per patient: 1.64), with a technical success rate of 97.6 % and a PES rate of 9.3 %. Major complications occurred in 6.8 % of patients and 4.1 % of procedures. There were no treatment-related deaths. Doxorubicin dose was an independent predictor of complications (p = 0.01). Four patients were lost to follow-up and 18 received liver transplants. Objective response rates were 74.6 %, 45.7 %, and 44.1 % at 6, 12, and 24 months, respectively. The cumulative 24-month overall survival rate was 55.96 %. Median survival was 22 months (interquartile range = 13-24). Co-morbidities and tumour response were independent predictors of survival (p = 0.0012 and 0.0052, respectively). Complications did not affect survival (p = 0.24).
DEB-TACE with tightly calibrated 100-μm beads is safe and not associated with increases in biliary toxicity or complications. Tumour response and survival are in the expected range for chemoembolisation therapy. (Clinical trials ID: NCT02670122).
评估使用紧密校准的 100μm 微球进行经动脉载药微球化疗栓塞术（DEB-TACE）治疗肝细胞癌（HCC）的安全性和耐受性。
这是一项多中心前瞻性研究，纳入了 131 例患者进行为期 2 年的随访。所有患者的 Child-Pugh 评分均≤B7，表现状态良好，巴塞罗那临床肝癌分期为 A 期或 B 期。微球中装载有 50mg/ml 的多柔比星。共治疗了 223 个结节（平均大小：27.6mm，平均每位患者的结节数：1.7 个）。使用不良事件通用术语标准 4.03 评估毒性，根据实体瘤反应评价标准修改版评估反应。主要终点是安全性。次要终点包括技术成功率、栓塞后综合征（PES）、局部肿瘤反应和 2 年生存率。
共进行了 214 次 DEB-TACE 手术（平均每位患者 1.64 次），技术成功率为 97.6%，PES 发生率为 9.3%。主要并发症发生在 6.8%的患者和 4.1%的手术中。无治疗相关死亡。多柔比星剂量是并发症的独立预测因素（p=0.01）。4 例患者失访，18 例接受了肝移植。6、12 和 24 个月时的客观缓解率分别为 74.6%、45.7%和 44.1%。累积 24 个月总生存率为 55.96%。中位生存期为 22 个月（四分位距=13-24）。合并症和肿瘤反应是生存的独立预测因素（p=0.0012 和 0.0052）。并发症对生存无影响（p=0.24）。
使用紧密校准的 100μm 微球进行 DEB-TACE 是安全的，不会增加胆道毒性或并发症。肿瘤反应和生存处于化疗栓塞治疗的预期范围内。（临床试验注册号：NCT02670122）。
